RNA Supply Chain

SUPPLY CHAIN ARTICLES

The Price Is… Almost Right: mRNA Edition! COGS Reduction Strategies
The following article will outline the current state of COGS in the mRNA industry and the work he and his colleagues undertook to more effectively utilize raw materials. But heaven forbid this be your normal conference panel write-up. No, below I share Parrella’s insights, but in the form of a never-before released episode of The Price is Right…or perhaps more fittingly given the state of the industry today, this spectacle is more aptly titled: The Price is…Sort Of, Almost, Not Quite Right!
Assessing Quality Of mRNA Vaccines: Key Considerations
To address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.
The RNA Therapeutics Supply Chain: A Platform of Relationships
Conversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.
mRNA Vaccines: Key Considerations For Development & Manufacturing
As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more.
A "Hot Take" on Personalized mRNA Medicines
mRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.
Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.

SUPPLY CHAIN VIDEOS

Next-Generation RNA Modality Supply Considerations

Together, Life Edit Therapeutics’ April Sena and Sanofi’s Troiano share their perspectives on raw material quality & IP-related considerations for managing the supply chain for next-generation RNA modalities.

Single-Use Technology For Quality mRNA Manufacturing

Learn how single-use technologies deliver important benefits for mRNA manufacturing, including increased speed, quality, flexibility, and adaptability to different dosages and scale-up strategies.

Defining Phase-Appropriate GMP Principles: Where Do We Start?

In this excerpt from Advancing RNA Live's Got Raw Materials? The State Of The mRNA Supply Chain featured guests share how they and their teams align around the definition of “phase-appropriate.”

Addressing mRNA's Scalability And Supply Challenges

Tune in as Roberta Duncan, VP of the mRNA program at Seqirus; Duke Human Vaccine Institute Associate Director of Upstream and Downstream Process Development Jason Dickens, Ph.D.; and Jin Zhou, Executive Director of Process Development for mRNA and Protein Biologics at Ultragenyx share supply chain and manufacturing capacity constraints in the face of the urgency to address COVID-19. This is an excerpt from the Bioprocess Online Live event - mRNA Manufacturing: Bright Future, Big Challenges.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

Review Of mRNA Vaccines & Therapeutics Manufacturing Challenges: Plasmid DNA Manufacturing

This review suggests technical remedial options for the production of pDNA and focuses on mRNA synthesis, purification, and encapsulation.
Optimization Of Transient Transfection Of MSCs With Plasmid DNA Or mRNA

Read through the results of our efforts to produce an optimal protocol for the transient transfection of hMSCs with pDNA or mRNA using non-viral means.
GMP-Source® And Phase-Appropriate Use For Early-Stage Clinical Trials

GMP-Source is a more robust, less rigid alternative to full cGMP production that mirrors nearly all of the oversight and quality standards of full cGMP production while relaxing certain commercial standards, helping companies overcome the hurdles that can stall early development.
Transitioning From Using RUO To cGMP Chemicals For Clinical Trials

Learn about the common challenges and risks associated with accelerating your molecule's timeline from lab to clinic, along with important supply chain considerations for emerging biopharma companies.
Consolidating The Supply Chain For mRNA

Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.
Chromatographic Purification Of Plasmid DNA

Widespread application of pDNA in gene therapy is driving increased demand and as a response, plasmid manufacturing must become more efficient with improved productivity. Intensification of chromatographic steps can help address this demand and has led to an exploration of the use of convective media (monoliths, membranes, fibre based technologies).
The Role Of CRISPR Cas9 Plasmids In Gene-Editing

Plasmids are crucial for CRISPR-Cas9 gene-editing technology, and their role in CRISPR is expected to evolve with ongoing research.

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